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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN PD CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING
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UNKNOWN PD CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING Back to Search Results
Device Problems Flushing Problem (1252); Migration or Expulsion of Device (1395)
Patient Problem Pain (1994)
Event Date 02/20/2021
Event Type  Injury  
Event Description
It was reported that a peritoneal dialysis (pd) patient when to the hospital due to peritoneal not flushing their system.The patient stated they were in so much pain.Radiological testing determined the patient's pd catheter (not a fresenius product) had migrated out of position and would require surgical intervention.On (b)(6) 2021, the patient underwent a pd catheter revision and the surgical placement of a temporary hemodialysis (hd) catheter (not a fresenius product).The patient's pd catheter was successfully revised, and per the surgeon's orders, the patient was transitioned to 'back-up' hd for two weeks.The patient underwent several hd treatments while hospitalized without issue and was discharged on (b)(6) 2021.The patient is recovering from the events and is scheduled to resume continuous cycling peritoneal dialysis (ccpd) therapy on (b)(6) 2021 utilizing the same liberty select cycler as before the event(s).The porn stated the events were unrelated to a fresenius device(s) and/or product(s) deficiency or malfunction.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
PD CATHETER
Type of Device
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Manufacturer (Section D)
UNKNOWN
MDR Report Key17534931
MDR Text Key321153407
Report NumberMW5141831
Device Sequence Number1
Product Code FJS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 03/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Patient Sequence Number1
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